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Complete guide of pharmacovigilance standard operating procedure

Basic Guide to Writing Effective Pharmacovigilance Standard Operating Procedures (SOPs)

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Pharmacovigilance Standard Operating Procedures (SOPs) are the foundation of every reliable PV system. Well-written SOPs are the backbone of your pharmacovigilance (PV) system: they encode legal obligations into daily practice, reduce variability, protect data integrity, and demonstrate control during inspections. They transform global regulatory requirements into clear, actionable workflows that ensure patient safety, regulatory compliance, and […]

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Insights on Regulatory Requirements for QPPV and Deputy QPPV in Saudi Arabia

Regulatory Insight for QPPV and Deputy QPPV Appointments in Saudi Arabia 

All Category, Blogs, Pharmacovigilance /

In the global pharmaceutical market, ensuring drug safety through proper pharmacovigilance practices is paramount. Regulatory agencies around the world mandate robust systems to monitor, assess, and report adverse drug reactions (ADRs) in a timely manner. In Saudi Arabia, the Saudi Food and Drug Authority (SFDA) plays a crucial role in overseeing the safety of pharmaceutical

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PV Requirements for medical devices and combination products

Global Pharmacovigilance Requirements for Devices and Combination Products

All Category, Blogs, Medical Device, Pharmacovigilance /

The traditional boundaries separating pharmaceuticals, biologics, and medical devices have blurred. With the rise of combination products, from drug-eluting stents and prefilled autoinjectors to inhalers with embedded sensors, the regulatory landscape has undergone a seismic shift. While pharmacovigilance (PV) for pharmaceuticals is well-established, the safety monitoring of PV for devices and combination products introduces distinct technical and

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ost-market evidence generation for long-term healthcare access in PV and HTA

Post-Market Evidence Generation: Bridging PV and HTA for Long-Term Access

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Post-market evidence generation is becoming a strategic priority for life sciences companies. After a drug or medical device gains regulatory approval, the focus quickly shifts to long-term access, pricing, and continued patient benefit. This shift requires new, real-world evidence to validate both product safety and health system value.  At the intersection of pharmacovigilance (PV) and

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Evolution of EU drug safety reporting tools

Evolving Safety Reporting in the EU: Beyond EudraVigilance to EVDAS & SPOR 

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With safety reporting in the European Union (EU) entering a new era of digital integration and oversight, pharmacovigilance systems have become more connected, data-driven, and strategically central to regulatory compliance. What once revolved around manual case handling and isolated national databases has transformed into a highly interconnected pharmacovigilance network. This shift is not only redefining

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Types of vigilance in life science industry

Types of Vigilance Every Life Sciences Professional Should Know 

All Category, Blogs, Pharmacovigilance, regulatory /

In the global life sciences industry, whether you’re launching a new pharmaceutical, a medical device, or a personal care product, the responsibility doesn’t end at regulatory approval. It extends across the product lifecycle, driven by a commitment to patient and consumer safety, and reinforced by an evolving web of global regulatory requirements.    Traditionally associated

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Automating Medical and Scientific Literature Monitoring for Drug Safety

Automation of Literature Monitoring for Pharmacovigilance

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Literature monitoring, a key component of pharmacovigilance (PV), involves searching and analyzing medical and scientific publications, including journal articles, case reports, conference abstracts, and online content to identify reports of ADRs, safety signals, or other pertinent information. This surveillance is essential for detecting previously unknown adverse reactions or risks that may not have emerged during

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Role of Pharmacovigilance Audits in Drug safety

Pharmacovigilance Audits: Ensuring Drug Safety

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Edit with Elementor Loading Behind every safe and effective medicine on the market lies a complex system of checks and balances and key parameter of that system are pharmacovigilance (PV) audits. While they might not grab headlines like clinical trials or breakthrough approvals, PV audits are the quiet guardians of drug safety, ensuring that pharmaceutical

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REMS Audits and Inspections

REMS Audits and Inspections: What You Need to Know

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Risk Evaluation and Mitigation Strategies (REMS) are special safety programs required by the U.S. Food and Drug Administration (FDA) for certain drugs and biologics with serious safety concerns. These programs are designed to ensure that a product’s benefits outweigh its risks. REMS may include strategies such as restricted distribution, prescriber certification, patient education, training, and

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Key Developments & Implications of the European Health Data Space

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In an age where data is often called the new oil, the healthcare sector is sitting on a goldmine of untapped potential. Every day, vast amounts of health data are generated across the European Union, offering incredible opportunities to transform the way healthcare is delivered, researched, and managed. Enter the European Health Data Space (EHDS)—a

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